Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus.

NCT07203664 | Not Yet Recruiting Phase 4

• 1 other identifier: TIMTOR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this project is to optimise preventive treatment of CMV infection/disease in renal transplant recipients at increased risk of CMV post-transplantation. The specific objectives are: (1) To compare the incidence of CMV infection/disease at 6 months post-transplant in Ig G CMV positive (R+CMV) recipients receiving induction treatment with thymoglobulin and one of the two maintenance immunosuppressive treatment regimens used in routine clinical practice : tacrolimus and MTOR inhibitors (group 1) or tacrolimus and mycophenolic acid (group 2); (2) To monitor CMV-specific cellular immunity before transplantation, at 15, 30 and 90 days post-transplantation. For this purpose, an exploratory phase 4 clinical trial has been designed in which will select 30 R+CMV patients receiving renal transplantation with induction treatment with thymoglobulin. After signing informed consent, patients will be randomised to receive one of the two immunosuppression regimens indicated above. The patients in group 1 will receive early therapy as a CMV prevention strategy and patients in group 2 will receive universal prophylaxis for 3 months. Follow-up visits to will be conducted according to the usual protocol and clinical and virological variables will be collected. In addition, blood samples will be collected for the assessment of CMV-specific cellular immunity before and after transplantation. The primary endpoint is the presence of CMV infection/disease post-renal transplantation at 6 months. Secondary variables include renal function, acute rejection, patient and graft survival and the occurrence of surgical or haematological complications.

Conditions

Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (2)

• CMV disease incidence

  To compare the incidence of CMV disease at 6 months post-renal transplantation in Ig G CMV-positive recipients receiving induction treatment with thymoglobulin and maintenance treatment with tacrolimus and mTOR inhibitors (group 1) with CMV prevention strategy of early therapy or tacrolimus and mycophenolic acid (group 2) with CMV prevention strategy with universal prophylaxis.

  6 months after renal transplant

• Monitor CMV-specific cellular immune response prior to transplantation

  Monitor CMV-specific cell-mediated immune response before transplantation and at 15, 30 and 90 days post-transplantation in each of the two treatment groups using Quantiferon-CMV.

  4 months

Secondary Outcomes (2)

• To compare between the two groups the incidence of CMV infection, delayed initial graft function, acute rejection diagnosed by renal biopsy, renal function and patient and graft survival

  6 months

• To compare the presence of surgical (lymphocele requiring intervention) or haematological (neutropenia) complications

  6 months

Study Arms (2)

mTOR inhibitors

EXPERIMENTAL

Preemptive therapy will be administered as a preventive strategy, consisting of initiating antiviral treatment with valganciclovir (900 mg every 12 hours, adjusted according to renal function as per the technical data sheet) when CMV viral replication in blood exceeds 1,000 copies/ml. Treatment will be discontinued once viral load becomes undetectable in two consecutive tests

Combination Product: steroids, tacrolimus and mTOR inhibitors

Universal prophylaxis

ACTIVE COMPARATOR

As a preventive strategy against CMV, the patient will receive universal prophylaxis, and for maintenance immunosuppressive treatment, steroids, tacrolimus, and mycophenolic acid will be administered.

Combination Product: steroids, tacrolimus and mycophenolic acid.

Interventions

steroids, tacrolimus and mTOR inhibitors COMBINATION_PRODUCT

Patients receive immunosuppressive induction treatment with thymoglobulin (at least 1 dose and maximum of 5 doses) and immunosuppressive maintenance treatment with tacrolimus + mTOR inhibitors. Preemptive therapy will be administered as a preventive strategy, consisting of initiating antiviral treatment with valganciclovir (900 mg every 12 hours, adjusted according to renal function as per the technical data sheet) when CMV viral replication in blood exceeds 1,000 copies/ml. Treatment will be discontinued once viral load becomes undetectable in two consecutive tests.

mTOR inhibitors

steroids, tacrolimus and mycophenolic acid. COMBINATION_PRODUCT

Patients will receive immunosuppressive induction treatment with thymoglobulin (at least 1 dose and a maximum of 5 doses) and tacrolimus + mycophenolic acid following the guidelines of the technical file and the centre's usual protocols.

Universal prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or more.
• Positive pre-transplant Ig G CMV serology.
• Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).
• Agree to participate in the study by signing the informed consent form.

You may not qualify if:

• Patients with negative pre-transplant Ig G CMV serology.
• HIV-infected patients.
• Patients receiving induction therapy with basiliximab.
• Patients who cannot comply with the follow-up protocol.
• Patients who cannot receive iMTOR as initial maintenance immunosuppressive therapy, such as patients with chronic kidney disease secondary to hepatorenal polycystic kidney disease and patients who are expected to undergo complex vascular surgery.
• Patients who for any reason should not be included in the study according to the evaluation of the research team.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz, Pº de la Castellana, 261 (Servicio de Nefrologia)

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Interventions

Steroids; Tacrolimus; MTOR Inhibitors; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones; Organic Chemicals; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Therapeutic Uses; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Central Study Contacts

María O. López Oliva, Dra

CONTACT

+34 91 727 70 00; mlopezo@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra.

Model Details: exploratory, randomised, open-label, single-centre trial

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 2, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)